[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500447":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":46,"locations":57,"responsibleParty":216,"collaborators":219,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":229,"sex":234,"minAge":235,"maxAge":31,"enrollmentInfo":236,"targetDuration":31,"studyType":239,"phases":240,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"White River Junction Veterans Affairs Medical Center","FED",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Frequent Cystoscopy","ACTIVE_COMPARATOR","Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer",[13],"Procedure: Cystoscopy",{"label":15,"type":16,"description":17,"interventionNames":18},"Xpert Urine Test","EXPERIMENTAL","Xpert arm includes urine testing using the Xpert Bladder Cancer Monitor urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer",[13,19],"Diagnostic Test: Xpert Bladder Cancer Monitor urine test",{"label":21,"type":16,"description":22,"interventionNames":23},"EpiCheck Urine Text","EpiCheck arm includes urine testing using the Bladder EpiCheck urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer.",[13,24],"Diagnostic Test: Bladder EpiCheck urine test",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Cystoscopy","Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.",[21,9,15],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DIAGNOSTIC_TEST","Bladder EpiCheck urine test","The Bladder EpiCheck is a laboratory-developed test for early-stage non-muscle invasive bladder cancer. The Bladder EpiCheck test is a DNA methylation test that is run on DNA extracted from cell pellet from centrifuged urine according to Standardized Operating Procedures. The test has internal controls and a dedicated software to ensure required quality assurance processes and prompt reporting of results.",[21],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Xpert Bladder Cancer Monitor urine test","A 4.5 ml sample of voided urine is added to Xpert® Urine Transport Reagent, mixed, and then 4ml of treated urine are transferred to the Sample Chamber of the cartridge. In the cartridge, cells in the urine sample are captured on a filter and lysed by sonication. The released nucleic acid is eluted, mixed with dry RT-PCR reagents, and the solution is transferred to the reaction tube for RT-PCR and detection.",[15],[42],{"name":43,"affiliation":44,"role":45},"Florian R Schroeck, MD, MS","White River Junction VA Healthcare System","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Prabhavathi Loganathan, MS","CONTACT","802-295-9363","6914","Prabhavath.Loganathan@va.gov",{"name":54,"role":49,"phone":55,"phoneExt":31,"email":56},"Laura Jensen, MPH","802-280-5298","Laura.Jensen@va.gov",[58,80,98,119,137,155,172,183,199],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"West Haven VA Medical Center","RECRUITING","West Haven","Connecticut","06516","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-72.94705,41.27065,{"lat":70,"lon":69},[73,78],{"name":74,"role":49,"phone":75,"phoneExt":76,"email":77},"Alicia Roy","203-932-5711","3006","Alicia.Roy@va.gov",{"name":79,"role":45,"phone":31,"phoneExt":31,"email":31},"Fady Ghali, MD",{"facility":81,"status":60,"city":82,"state":83,"zip":84,"country":64,"countryCode":65,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Bay Pines VA Healthcare System","Bay Pines","Florida","33744",{"type":67,"coordinates":86},[87,88],-82.77816,27.81419,{"lat":88,"lon":87},[91,96],{"name":92,"role":49,"phone":93,"phoneExt":94,"email":95},"Anna Rosenblatt","727-398-6661","17051","Anna.Rosenblatt2@va.gov",{"name":97,"role":45,"phone":31,"phoneExt":31,"email":31},"Andrew Leone, MD",{"facility":99,"status":60,"city":100,"state":83,"zip":101,"country":64,"countryCode":65,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"James A. Haley Veterans' Hospital","Tampa","33612",{"type":67,"coordinates":103},[104,105],-82.45843,27.94752,{"lat":105,"lon":104},[108,113,117],{"name":109,"role":49,"phone":110,"phoneExt":111,"email":112},"Adam Zoble, MS","813-972-2000","106939","Adam.Zoble@va.gov",{"name":114,"role":49,"phone":110,"phoneExt":115,"email":116},"Mckayla L Sundin, BS","102342","Mckayla.Sundin@va.gov",{"name":118,"role":45,"phone":31,"phoneExt":31,"email":31},"Cesar E Ercole, MD",{"facility":120,"status":60,"city":121,"state":122,"zip":123,"country":64,"countryCode":65,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"VA Boston Jamaica Plains Campus","West Roxbury","Massachusetts","02132",{"type":67,"coordinates":125},[126,127],-71.1495,42.27926,{"lat":127,"lon":126},[130,134],{"name":131,"role":49,"phone":132,"phoneExt":31,"email":133},"Laura MacAdam, NP","857-407-8074","Laura.MacAdam@va.gov",{"name":135,"role":136,"phone":31,"phoneExt":31,"email":31},"Lori Lerner, MD","SUB_INVESTIGATOR",{"facility":138,"status":60,"city":139,"state":140,"zip":141,"country":64,"countryCode":65,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"VA St.Louis Healthcare System","St Louis","Missouri","63016",{"type":67,"coordinates":143},[144,145],-90.19789,38.62727,{"lat":145,"lon":144},[148,153],{"name":149,"role":49,"phone":150,"phoneExt":151,"email":152},"Carley Browning","314-652-4100","57697","Carley.Browning@va.gov",{"name":154,"role":45,"phone":31,"phoneExt":31,"email":31},"Lewis Thomas, MD",{"facility":156,"status":60,"city":157,"state":158,"zip":159,"country":64,"countryCode":65,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":67,"coordinates":161},[162,163],-81.69541,41.4995,{"lat":163,"lon":162},[166,170],{"name":167,"role":49,"phone":168,"phoneExt":31,"email":169},"Imani Lucas, MPH","216-767-1027","Imani.Lucas@UHHospitals.org",{"name":171,"role":45,"phone":31,"phoneExt":31,"email":31},"Randy Vince, MD",{"facility":173,"status":174,"city":175,"state":176,"zip":177,"country":64,"countryCode":65,"cosmosGeoPoint":178,"geoPoint":182,"contacts":31},"Medical University of South Carolina","ACTIVE_NOT_RECRUITING","Charleston","South Carolina","29425",{"type":67,"coordinates":179},[180,181],-79.93275,32.77632,{"lat":181,"lon":180},{"facility":184,"status":60,"city":185,"state":186,"zip":187,"country":64,"countryCode":65,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"UT Southwestern Medical Center","Dallas","Texas","75235",{"type":67,"coordinates":189},[190,191],-96.80667,32.78306,{"lat":191,"lon":190},[194,197],{"name":195,"role":49,"phone":31,"phoneExt":31,"email":196},"Sonobia Garrett, BSHS","Sonobia.Garrett@utsouthwestern.edu",{"name":198,"role":45,"phone":31,"phoneExt":31,"email":31},"Yair Lotan, MD",{"facility":200,"status":60,"city":201,"state":202,"zip":203,"country":64,"countryCode":65,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"White River Junction Veterans Healthcare System","White River Junction","Vermont","05009",{"type":67,"coordinates":205},[206,207],-72.31926,43.64896,{"lat":207,"lon":206},[210,213,215],{"name":211,"role":49,"phone":50,"phoneExt":51,"email":212},"Prabha L Loganathan, MS","prabhavath.loganathan@va.gov",{"name":54,"role":49,"phone":50,"phoneExt":214,"email":56},"6953",{"name":43,"role":45,"phone":31,"phoneExt":31,"email":31},{"type":45,"investigatorFullName":217,"investigatorTitle":218,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Florian Schroeck","Chief, Section of Urology",[220,223,226],{"name":221,"class":222},"National Cancer Institute (NCI)","NIH",{"name":224,"class":225},"University of Texas Southwestern Medical Center","OTHER",{"name":173,"class":225},"100500447","phase-2-replacing-invasive-cystoscopy-with-urine-testing-for-non-muscle-invasive-bladder-cancer-surveillance-100500447",false,"NCT05796375","Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance","ReplaceCysto","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:\n\n   * multifocal low grade non-invasive urothelial carcinoma of any size\n   * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size\n   * recurrent low grade non-invasive urothelial carcinoma\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection\n5. Ability to consent in English or Spanish\n\nExclusion Criteria:\n\n1. History of total cystectomy of the bladder.\n2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).\n3. History of muscle-invasive bladder tumor.\n4. Pregnancy or lactation.\n5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)\n6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).\n7. Inability to provide a voided urine sample.","ALL","18 Years",{"count":237,"type":238},240,"ESTIMATED","INTERVENTIONAL",[241],"PHASE2","The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.",[244],"Non-muscle-invasive Bladder Cancer",[246,247,248,28,249,250,251],"Bladder","Cancer","Urology","Xpert","EpiCheck","Urine test","2026-05-01",{"date":254,"type":255},"2026-05-04","ACTUAL",{"date":257,"type":255},"2023-11-17",{"date":259,"type":238},"2028-12-30",{"name":5,"class":6},9]